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The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology Analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.

The product is an automated hematology analyzer capable of supplying a complete blood cell analysis and includes a differential leukocyte cell count. The product also provides automated reticulocyte analysis, enumeration of nucleated red blood cells (NRBCs) in whole blood and leukocytes (WBC) and erythrocytes (RBC) in cerebrospinal fluid, serous fluids, and synovial fluid. The COULTER LH 750 Hematology Analyzers utilizes the Coulter Principle for enumerating and sizing blood cells, automatic and manual modes for sample processing and a single beam photometer for hemoglobinometry. They use COULTER VCS (volume, conductivity, light scatter) technology for leukocyte differentiation and reticulocyte analysis. The analyzers use a reagent system consisting of an isotonic diluent, lytic reagents, and instrument cleaner. Additionally, all systems include reagents used for reticulocyte staining and analysis.

The provided text describes a 510(k) submission for a modification to the COULTER® LH 750 Hematology Analyzer, specifically related to the NRBC QC method. However, the document does not contain an independent clinical study that establishes acceptance criteria and then demonstrates the device meets those criteria through performance data.

Instead, this 510(k) is a Special 510(k), which is used for modifications to a legally marketed device where the modification does not affect the device's fundamental scientific technology or intended use, and the performance data necessary to demonstrate substantial equivalence can be found in the original premarket notification or in recognized standards. In this case, the modification is to the NRBC QC method, suggesting an administrative or minor technical change rather than a re-evaluation of the core performance of the analyzer itself.

Therefore, many of the requested sections (e.g., sample size for test set, ground truth experts, MRMC study, standalone performance) are not applicable or extractable from this specific document, as those would typically be part of a full 510(k) submission for a new device or a significant modification requiring extensive re-validation.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available in the provided document. The document refers to a modification to the "NRBC QC Method" and states "The modified COULTER® LH 750 Hematology Analyzer claims substantial equivalence to the previously cleared COULTER® LH 750 Hematology Analyzer." This implies that the performance characteristics (accuracy, precision, etc.) for the NRBC enumeration itself would have been established and accepted under the original clearance (K011342). This submission focuses on the QC method for those NRBC determinations, not on the underlying performance specifications of the NRBC enumeration itself.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable/Not provided. This submission is for a modification to a QC method, not a re-evaluation of the device's overall performance that would typically involve a test set for clinical accuracy. The original 510(k) (K011342) would contain this information for the device's initial clearance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable/Not provided. Similar to the above, this information would be relevant to the original clearance of the device's performance, not this specific modification to a QC method.

4. Adjudication Method for the Test Set:

Not applicable/Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This type of study is typically done for diagnostic imaging or interpretation tasks where multiple human readers are involved. A hematology analyzer, while performing complex analysis, is generally evaluated through its analytical performance (accuracy, precision, linearity) against reference methods, not typically in an MRMC setting for human reader improvement.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

The COULTER® LH 750 Hematology Analyzer is an automated device, so its primary function is standalone (without human-in-the-loop performance for the core analysis). However, this document does not present a study demonstrating its standalone performance for the NRBC QC method modification. The standalone performance of the NRBC enumeration would have been established during the original K011342 submission.

7. The Type of Ground Truth Used:

For the original clearance of a hematology analyzer, ground truth for cell counts and differentials typically involves:

• Reference methods: Manual microscopy by trained technologists/pathologists, often with differential counts performed on stained blood smears.
• Certified reference materials: Materials with known values for specific analytes (e.g., cell counts).
• Comparison to predicate devices: Performance compared to existing, legally marketed devices.

This specific document related to the modification of the NRBC QC method doesn't discuss the ground truth for NRBC enumeration itself, but rather how the quality control for that enumeration is monitored.

8. The Sample Size for the Training Set:

Not applicable/Not provided. The COULTER® LH 750 (and its underlying technology) was developed prior to the widespread use of "training sets" in the context of machine learning algorithms as we understand them today for image recognition, etc. While the instrument relies on algorithms, these are more in the realm of signal processing and pattern recognition engineered based on established hematological principles rather than deep learning requiring large, labeled training datasets in the contemporary sense. Any "training" or calibration would typically involve a smaller set of known samples to fine-tune instrument parameters.

9. How the Ground Truth for the Training Set Was Established:

Not applicable/Not provided. If "training set" refers to calibration materials, their ground truth would be established through a combination of reference methods and certified values.

In summary, the provided document is a notification for a minor modification to a previously cleared device's QC method. It does not contain an independent study with acceptance criteria and performance data for the device itself because the original device's performance was already established and cleared under a prior 510(k).

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The COULTER® LH 750 Hematology Analyzer is a quantitative, automated hematology Analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER® LH 750 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs).

The product is an automated hematology analyzer capable of supplying a complete blood cell analysis and includes a differential leukocyte cell count. The product also provides automated reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs). The COULTER LH 750 Hematology Analyzer with Version 2A software has the same technological characteristics and is substantially equivalent to the COULTER LH 750 Hematology Analyzer with Version 1A software. Both devices utilize the Coulter Principle for enumerating and sizing blood cells, automatic diluting and mixing for sample processing and a single beam photometer for hemoglobinometry. They use COULTER VCS (volume. conductivity, light scatter) technology for WBC Differential analysis and classification and reticulocyte analysis. The analyzers use a reagent system consisting of an isotonic diluent. lytic reagents to lyse the red cells without significantly affecting the white cells and an instrument cleaner. Additionally, all systems include reagents used for reticulocyte staining and analysis.

The provided text is limited and primarily focuses on the regulatory information, device description, and indications for use of the COULTER® LH 750 Hematology Analyzer with Version 2A Software. It explicitly states that this submission is a "Summary of Safety and Effectiveness," usually followed by a more detailed report or study.

Based on the provided text, a comprehensive acceptance criteria table and the study to prove it cannot be fully constructed because the detailed study results and specific acceptance criteria values are not included. The document acts as a 510(k) submission summary, indicating substantial equivalence to a predicate device, rather than a full study report with detailed performance metrics against predefined acceptance criteria.

However, I can extract the available information and highlight what is missing based on your request.

Acceptance Criteria and Device Performance

Due to the lack of specific performance data and predefined acceptance criteria in the provided text, this table will show what the document claims the device does (performance characteristics) and what would typically be expected as acceptance criteria for such a device.

Study Details (Based on available information in the document)

Given the nature of a 510(k) for a software/minor hardware update to an existing device, the "study" described is primarily focused on demonstrating substantial equivalence to the predicate device. The provided text is a summary and therefore lacks the granular detail of a full study report.

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: Not specified in the provided text.
   • Data Provenance: Not specified. It's common for such studies to involve samples from clinical laboratories, potentially across various demographics, but this information is absent here. The submission is from Beckman Coulter, Inc., Miami, FL, USA, suggesting the primary regulatory interaction and potentially the core development location.
   • Retrospective or Prospective: Not specified.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

   • Not specified. For automated differential cell counters, ground truth is typically established through manual microscopic review by trained technologists or hematopathologists.

3. Adjudication Method for the Test Set:

   • Not specified.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study is not explicitly mentioned or described. This type of study is more common for diagnostic imaging AI where human interpretation (readers) is a key part of the workflow. For an automated hematology analyzer, the focus is on the device's analytical performance (accuracy, precision, correlation to a reference method, or the predicate device), not typically on how it "improves" human reader performance in a diagnostic read, as the device itself provides the result.

5. Standalone (Algorithm Only) Performance Study:

   • Yes, implicitly. The device is an "automated differential cell counter" and provides "automated reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs)." This means the algorithm performs these analyses without human intervention for each count. The "study" for a 510(k) of this nature would involve evaluating how well the device's automated counts agree with a reference method (e.g., manual microscopy) or with the predicate device. Specific standalone performance metrics (e.g., sensitivity, specificity, accuracy for flagging abnormal cells, or correlation coefficients for cell counts) are not provided in this summary.

6. Type of Ground Truth Used:

   • Not explicitly stated, but for hematology analyzers, typical ground truth involves:
     • Manual microscopy (expert review): For cell differentials, morphology, and difficult-to-classify cells.
     • Reference methods: For precise cell counts (e.g., flow cytometry for certain subpopulations or highly calibrated manual counts).
     • Predicate device results: For demonstrating substantial equivalence, direct comparison to the previous version's results is critical.

7. Sample Size for the Training Set:

   • The term "training set" is not mentioned, as this document describes a conventional medical device modification, not necessarily an AI/machine learning model in the modern sense that requires a distinct training phase. If the software improvements involved algorithmic adjustments, it implies development and testing data, but no specific "training set" size is provided.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable as "training set" for an AI model is not described. For general software development and validation, ground truth would typically be established by established laboratory methods, manual review, or comparison to existing validated systems.

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